Nuedexta for the Treatment of Adults With Autism

Trial end date:
Target enrollment:
Participant gender:
Primary: Demonstrate reduced frequency and intensity of maladaptive behaviors as measured by the Aberrant Behavior Checklist (ABC) Irritability subscale in subjects given Nuedexta 8 weeks over subjects given placebo. Secondary: Demonstrate a trend towards reduced aggressive behavior as measured by Overt Aggression Scale (OAS).
Phase 2
Accepts Healthy Volunteers?
Lead Sponsor:
Sutter Health
Quinidine gluconate
Inclusion Criteria:

1. 18 to 60 years of age

2. Have a collateral informant who can attend visit and answer questionnaires pertaining
to participant behavior

3. Diagnosis of autistic spectrum disorder based on the Diagnostic and Statistical
Manual, 4th edition, Text Revised (DSM-IV-TR) criteria, developmental history, and
Autism Diagnostic Observation Schedule (ADOS); or confirmed diagnosis of autism during
childhood through similar methods

4. Capable of giving informed consent, or have a legal guardian capable of giving consent
on the subject's behalf; patient able to assent to participate

5. Mood issues and frontal lobe type perseveration issues

6. No medication changes within 30 days and no use of new medications during the course
of the study except for non-related conditions approved by the investigators

Exclusion Criteria:

1. Clinically uncontrolled epilepsy

2. Cardiovascular conditions including cardiac or structural malformation heart failure,
prolonged QT interval, history of torsades de pointes, or atrioventricular (AV) block

3. Known genetic disorders, fragile x, or known brain structural abnormalities, cerebral
palsy, head injury, or brain tumor

4. Known allergy to either dextromethorphan or quinidine

5. Concurrent or recent use of Monoamine oxidase inhibitor (MAOI) antidepressants pt

6. Concurrent use of lamotrigine or felbamate or other N-Methyl-D-aspartate (NMDA)
agonists or antagonists

7. Thrombocytopenia, hepatitis, bone marrow depression or lupus-like syndrome

8. Pregnancy - sexually active females of childbearing potential must be on a reliable
form of contraception

9. Other clinically significant abnormality on physical, neurological, laboratory, vital
signs, that could compromise the study or be detrimental to the subject